Elekta Instrument AB has initiated a recall of Disposable Biopsy Needles used with the Leksell Stereotactic System, which is used for diagnosing brain disorders through precise tissue sampling. This recall, classified as Class I by the FDA — indicating the highest level of risk — stems from the discovery of microscopic stainless steel debris within the needles. This debris could potentially lead to severe medical complications, including interference with MR scans crucial for ongoing brain tumor management.

The recall affects a single lot of the biopsy needles (product code HAW, lot number 837838839), distributed in the U.S. from August 29, 2023, to January 5, 2024. Elekta disclosed that only 10 units are implicated in this recall, which was officially initiated by the firm on March 15, 2024.

Healthcare professionals using this system and patients undergoing procedures with these kits are at risk. If debris dislodges, it may contaminate biopsy samples, complicating or delaying crucial diagnostic analyses. If deposited in the brain, the long-term effects of such particles are currently unknown but could render future MR scans ineffective — a critical setback for brain tumor surveillance.

There have been no injuries or fatalities reported to be linked to the issue.

Elekta has issued an Urgent Recall Notification to its customers, instructing them to immediately cease using and dispose of all needles from the affected batch. The company is also facilitating the procurement of replacement kits and has requested that all recipients of the recall notification complete and return an acknowledgment form.

Learn more here.

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